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510(k) Data Aggregation

    K Number
    K073048
    Device Name
    PETERIO UNIVERSAL LASER SCANNING HANDPIECE
    Manufacturer
    Date Cleared
    2008-02-28

    (122 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    SCILEX, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.
    Device Description
    The Peterio™ Universal Laser Scanning Handpiece is an accessory for a legally marketed, compatible laser system. It is hand held device which attaches to the distal end of the laser system and delivers rapid scanning of the laser beam over a predetermined surface area. The Peterio has been designed for delivering the energy fluence equivalent to that of legally marketed compatible lasers, to a confined volume at a selectable tissue depth, while at the same time the Peterio exposes the tissue surface to less than 10% of the fluence of such lasers.
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